The Drug Technical Advisory Board (DTAB) has approved a proposal to amend the health ministry notification banning the retail sale of oxytocin in order “to ensure availability for human use”.
The DTAB chaired by the Director General of Health Services (DGHS) Dr S Venkatesh in a meeting held on July 25 deliberated on the proposal to amend the ministry notification issued on April 27. The notification had banned manufacture of the drug for domestic consumption by all private manufacturers and also stopped all retail sales through chemists from July 1. This was subsequently extended to August 31.
The board recommended that the clause in the notification related to selling the drug directly to registered hospitals and clinics only through Jan Aushadhi and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets and the clause banning retail sales through chemists be deleted.
The notification, which had cited the DTAB, had allowed private manufactures to continue producing the drug for export but not for sale in India. Only a single public sector unit, Karnataka Antibiotics and Pharmaceuticals Limited (KAPL), with no prior experience in manufacturing this drug, was allowed to produce and distribute it.
Oxytocin is an essential drug used to prevent and treat post-partum haemorrhage or excessive bleeding after child birth, one of the top causes for maternal deaths. Oxytocin is part of the government’s mandatory protocol for post-delivery management and is also used to induce uterine contractions to help normal delivery. There has been widespread panic among obstetricians and gynaecologists, who have been appealing to the government to reconsider the ban. Any problem in availability of the drug could lead to several women, especially those in remote areas, losing their lives, they pointed out, expressing concern about a single public sector unit being able to ensure availability of the drug in remote areas.
“In effect, the lower priced brands of private pharma companies, which are time-tested, will be replaced with the costly brand of the KAPL, which is a newcomer, in the name of misuse of oxytocin,” Dr KV Babu, a public health activist who has been opposing the ban, had pointed out.